Use of Ultrasound in Injections of Botulinum Toxin

NCT02566837 | Completed

• 2 other identifiers: 11 425 032012-A00004-39
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Intramuscular injections of botulinum toxin are currently the best focal treatment of spasticity, with clearly defined indications and role. French and European recommendations focus on the toxin's mode of administration, which must be as precise as possible. The toxin's specific action on motor endplates (blocking the release of acetylcholine) shows the importance of targeted injections within the muscle belly. The pain caused by these injections is due partly the number of injections (up to 30 in a single session), and partly to the use of electrical stimulation guidance. Prevention and alleviation of the pain caused by these injections have become a regulatory obligation since the law of 4 March 2002 relating to the rights of patients and the quality of the health system (" Any person has the right to receive relief from pain, which must, under all circumstances, be prevented, evaluated, taken into account and treated … ").

Conditions

Spasticity

Keywords

ultrasound; Electrical stimulation guidance; botulinum toxin

Outcome Measures

Primary Outcomes (1)

• pain caused by the injections

  pain evaluated by vertical visual analogue scale indexed

  inclusion

Secondary Outcomes (5)

• Compare the pain felt by the patient

  7 weeks after inclusion

• Compare the pain felt by the patient

  7 weeks after inclusion

• reduction of spasticity

  6-8 weeks after inclusion

• Compare the time required to perform the injections of botulinum toxin under ultrasound guidance and under electrical guidance.

  inclusion

• Compare the efficacy of the injections of botulinum toxin in terms of functional gain.

  6-8 weeks after inclusion

Study Arms (2)

ELEC

ACTIVE COMPARATOR

electrical stimulation guidance

Procedure: electrical stimulation

ECHO

EXPERIMENTAL

ultrasound guidance

Procedure: Ultrasound

Interventions

Ultrasound PROCEDURE

ultrasound imaging to guide the intramuscular injections of botulinum toxin : Ultrasound is used to identify the target muscle, and for guiding the insertion of the needle in the muscle. Once the needle is positioned, the botulinum toxin is injected

ECHO

electrical stimulation PROCEDURE

electrical stimulation (reference technique currently recommended over muscle palpation and anatomical landmarks) to guide intramuscular injections of botulinum toxin. Intramuscular injection is carried out in register with the zone where is located the theoretically target muscle. Electrical stimulation (mediated by the tip of the needle) used to verify the correct position of the needle, and reposition it if necessary. Once the needle is correctly positioned, the botulinum toxin is injected.

ELEC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with a spasticity associated with a central neurological lesion caused by vascular hemiplegia, head trauma, sequelae of cerebral anoxia, multiple sclerosis, spinal cord injury, or cerebral palsy.
• Patient with a spasticity with an indication for a focal treatment with intramuscular injections of botulinum toxin, and associated with:
• Functional discomfort
• Tardieu score ≥1 for one or several muscles in the upper and/or lower limbs
• Patient naive to intramuscular botulinum toxin injections, and in whom the physician wishes to use the Speywood botulinum toxin (Dysport).
• Patient able to self-evaluate the pain on a VAS and understand three successive instructions, such as those used in the Mini Mental Status(MMS).
• Patient able to give his/her consent to participate.
• Patients able to provide a signed informed consent freely for the study protocol and data collection.
• Patient with a recognised Long-Term Illness, and thus necessarily covered by the social security.

You may not qualify if:

• General contra-indications of botulinum toxin:
• History of myasthenia or Lambert-Eaton syndrome
• History of neuromuscular disease
• Previous surgery with curarization less than a month ago
• Treatment with aminosides, aminoquinoleines or cyclosporine
• Anticoagulant treatment: heparin administered with an electrical syringe or anticoagulant therapy with effective doses
• Legal incompetence (judicial protection, guardianship)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Rangueil Hospital

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Muscle Spasticity

Interventions

High-Energy Shock Waves; Electric Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Physical Stimulation; Investigative Techniques

Study Officials

• David GASQ, MD

  Service d'explorations fonctionnelles - Hôpital Rangueil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: October 2, 2015
• Study Start: February 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 2, 2015

Record last verified: 2015-09

Locations

FR (1)